Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection

Do not use for treating neonates and infants below one year old - drug alert EL (14)A/09 issued in June 2014 still stands (EL(15)A/11)

10 November 2015

Class 4 caution in use

Distribute to pharmacy and hospital ward level

MDR 43-06/14

Product details

Wockhardt UK Ltd

Amoxicillin Sodium 250mg Powder for Solution for Injection - PL 29831/0010

Amoxicillin Sodium 500mg Powder for Solution for Injection - PL 29831/0012

Amoxicillin Sodium 1g Powder for Solution for Injection - PL 29831/0011

Alert details

Drug alert number EL (14)A/09 in connection with the above products was issued on 9 July 2014. In this alert, healthcare professionals treating neonates and infants (below one year old) were asked not to use Wockhardt Amoxicillin Powder for Solution for Injection (all strengths and all batches) in such patients. This was a precautionary measure following receipt of a number of reports of extravasation and injections site reactions.

Since a broader investigation of factors which may have caused this issue is now ongoing within MHRA, the recommendations in EL (14)A/09 are still applicable. An update will be provided should the situation change. At this time, there is still no evidence to suggest that these products are defective.

Recipients of this drug alert should bring it to the attention of relevant contacts by copy of this letter.

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Wockhardt UK Ltd - Amoxicillin Sodium 1g, 250mg and 500mg Powder for Solution for Injection

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